Hand HygieneSIHAGNCT03588221
Simplifying the World Health Organization (WHO) Protocol for Hand Hygiene
A study testing four sets of hand hygiene measurements per participant in people with Hand Hygiene, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Non-inferiority in terms of reduction of bacterial counts will be investigated when combining the simpler three-step hand hygiene technique for the use of hand rub with a shorter application time of 15 seconds compared to the to the three steps technique with an application time of 30 seconds and the technique… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hand Hygiene
- What is being tested?
- four sets of hand hygiene measurements per participant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Jul 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult participants (≥18 years)
Who cannot join
- skin disorders as determined by a dermatologist
- inability to follow procedures
- insufficient knowledge of the project language
- inability to give informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Division of Infectious Diseases and Hospital Epidemiology
Basel, 4031
About this study
Official title: Simplifying the WHO Protocol for Hand Hygiene: Three Steps and 15 Seconds - a Randomized Cross-over Trial
Non-inferiority in terms of reduction of bacterial counts will be investigated when combining the simpler three-step hand hygiene technique for the use of hand rub with a shorter application time of 15 seconds compared to the to the three steps technique with an application time of 30 seconds and the technique consisting in six steps.
- Conditions
- Hand Hygiene
- Being tested
- four sets of hand hygiene measurements per participant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
four sets of hand hygiene measurements per participantProcedure or surgery
- Six-step hand hygiene technique with an application time of 30 seconds
- Six-step hand hygiene technique with an application time of 15 seconds
- Three-step hand hygiene technique with an application time of 30 seconds
- Three-step hand hygiene technique with an application time of 15 seconds
| Study group | Role | What they receive |
|---|---|---|
| Six-step hand hygiene technique with application time of 30 | Other | Not described Receives: Procedure: four sets of hand hygiene measurements per participant |
| Six-step hand hygiene technique with application time of 15 | Other | Not described Receives: Procedure: four sets of hand hygiene measurements per participant |
| Three-step hand hygiene technique with application time of 3 | Other | Not described Receives: Procedure: four sets of hand hygiene measurements per participant |
| Three-step hand hygiene technique with application time of 1 | Other | Not described Receives: Procedure: four sets of hand hygiene measurements per participant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of bacterial counts on hands pre and post hand hygiene measure
The log counts of bacteria detected on the dominant hand will be averaged separately for pre- and post values. Differences between pre- and post values, as well as in the mean logarithmic reduction in bacterial counts will be compared
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start16 Jul 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand HygieneStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized crossover trial, comparing the following four sets of hand hygiene measurements per participant: 1. Six-step hand hygiene technique with an application time of 30 seconds 2. Six-step hand hygiene technique with an application time of 15 seconds 3. Three-step hand hygiene technique with an application time of 30 seconds 4. Three-step hand hygiene technique with an application time of 15 seconds
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Tschudin Sutter, PD MD, Principal investigator, University Hospital Basel, CH-4031 Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588221
- Sponsor's protocol ID
- 2018-01049;me18Tschudin-Sutter
- Other IDs
- 2018
- Acronym
- SIHAG
- Status last verified
- Jan 2019
- First submitted
- 3 Jul 2018
- Last updated
- 9 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplifying the WHO Protocol for Hand Hygiene: Three Steps and 15 Seconds - a Randomized Cross-over Trial
- ClinicalTrials.gov ID
- NCT03588221
- Acronym / sponsor ID
- SIHAG / 2018-01049;me18Tschudin-Sutter
- Conditions
- Hand Hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 17 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-inferiority in terms of reduction of bacterial counts will be investigated when combining the simpler three-step hand hygiene technique for the use of hand rub with a shorter application time of 15 seconds compared to the to the three steps technique with an application time of 30 seconds and the technique consisting in six steps.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized crossover trial, comparing the following four sets of hand hygiene measurements per participant: 1. Six-step hand hygiene technique with an application time of 30 seconds 2. Six-step hand hygiene technique with an application time of 15 seconds 3. Three-step hand hygiene technique with an application time of 30 seconds 4. Three-step hand hygiene technique with an application time of 15 seconds
| Arm | Type | Receives |
|---|---|---|
| Six-step hand hygiene technique with application time of 30 | Other | Procedure: four sets of hand hygiene measurements per participant |
| Six-step hand hygiene technique with application time of 15 | Other | Procedure: four sets of hand hygiene measurements per participant |
| Three-step hand hygiene technique with application time of 3 | Other | Procedure: four sets of hand hygiene measurements per participant |
| Three-step hand hygiene technique with application time of 1 | Other | Procedure: four sets of hand hygiene measurements per participant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult participants (≥18 years)
Key exclusion criteria (4 listed)
- skin disorders as determined by a dermatologist
- inability to follow procedures
- insufficient knowledge of the project language
- inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| four sets of hand hygiene measurements per participant1. Six-step hand hygiene technique with an application time of 30 seconds 2. Six-step hand hygiene technique with an application time of 15 seconds 3. Three-step hand hygiene technique with an application time of 30 seconds 4. Three-step hand hygiene technique with an application time of 15 seconds | Procedure or surgery | Six-step hand hygiene technique with application time of 15, Six-step hand hygiene technique with application time of 30, Three-step hand hygiene technique with application time of 1, Three-step hand hygiene technique with application time of 3 |
Primary outcome
Change of bacterial counts on hands pre and post hand hygiene measure
Time frame: 30 minutes
The log counts of bacteria detected on the dominant hand will be averaged separately for pre- and post values. Differences between pre- and post values, as well as in the mean logarithmic reduction in bacterial counts will be compared
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Tschudin Sutter, PD MD principal investigator
University Hospital Basel, CH-4031 Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing four sets of hand hygiene measurements per participant in people with Hand Hygiene, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of bacterial counts on hands pre and post hand hygiene measure (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.